STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5530-G-413 |
Device Problems
Degraded (1153); Material Integrity Problem (2978); Naturally Worn (2988)
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Patient Problems
Fall (1848); Injury (2348)
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Event Date 04/29/2016 |
Event Type
Injury
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Manufacturer Narrative
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When completed, the investigation results will be submitted in a supplemental report.
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Event Description
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Patient had a "controlled" fall and landed on the lateral side of her knee.Not exactly sure of time or date of the fall.All the collateral ligaments were intact at the time of the revision.The surgeon felt that he did'nt balance the knee well originally nine years ago and that caused her to wear significantly.
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Manufacturer Narrative
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An event regarding wear involving a triathlon insert was reported.The event was confirmed.Method & results: device evaluation and results: material analysis concluded; damage was observed on the medial condyle of the insert, consistent with the surgeon¿s comments.Scratches and third-body indentations were observed on articulating surfaces of the insert, which are a common damage mode of uhmwpe.No material or manufacturing defects were observed on the surfaces examined.Medical records received and evaluation: insufficient medical records were provided for review by a clinical consultant.Device history review: the device was manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the surgeon commented that he felt that he didn't balance the knee well originally nine years ago and that caused her to wear significantly.Material analysis concluded that the damage was observed on the medial condyle of the insert, consistent with the surgeon¿s comments.Scratches and third-body indentations were observed on articulating surfaces of the insert, which are a common damage mode of uhmwpe.No material or manufacturing defects were observed on the surfaces examined.Clinician review of the x-rays provided concluded: as such, no clear procedure-related causes for instability are present which by exclusion would leave the patient trauma as main cause of failure, a patient-related failure mode by definition.There is however not enough clinical information to establish such conclusions with enough certainty.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
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Event Description
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Patient had a "controlled" fall and landed on the lateral side of her knee.Not exactly sure of time or date of the fall.All the collateral ligaments were intact at the time of the revision.The surgeon felt that he did nto balance the knee well orginally nine years ago and that caused her to wear significantly.
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Search Alerts/Recalls
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